Job Description

Overview:
We are seeking a LIMS Specialist to join our GMP-regulated laboratory environment. The ideal candidate will manage day-to-day LIMS operations, lead and execute GMP validation and computerized system validation (CSV) activities, support system configuration and integration, and perform hands-on development where required. Strong French and English communication skills and adherence to regulated quality standards are essential. Qualifications:

• CFC or Bachelor's degree in Life Sciences, Computer Science, Information Systems or related field.
• Experience in GMP validation and CSV for laboratory computerized systems (IQ/OQ/PQ, validation protocols, traceability).
• Practical programming/scripting skills (e.g., Labware scripting, SQL, .NET, Python, or similar) for customization, report development and data integration.
• Understanding of laboratory workflows, sample lifecycle and data integrity principles.
• Familiar with integration technologies and protocols (e.g., REST/API, HL7, OPC, FTP, database interfacing).
• Excellent verbal and written French and English communication skills; able to produce

Responsibilities:

• Administer and maintain the Labware LIMS platform to ensure reliable, secure, and compliant operation in a GMP environment.
• Plan, execute and document GMP validation/CSV activities for LIMS changes, upgrades and integrations.
• Develop, review and maintain SOPs, work instructions and validation documentation related to LIMS operation and change control.
• Provide day-to-day operational support: access roles, troubleshooting, incident management and routine maintenance.
• Lead or support system integration projects (e.g., instruments, WMS, ELN, SAP) including requirements gathering, design, testing and deployment.
• Perform LIMS configuration, scripting and customization within Labware framework; develop and maintain custom modules, reports, queries and interfaces when necessary.
• Implement and support data integrity controls and best practices aligned with ALCOA+ principles.
• Train and support end users and prepare training materials.
• Participate in change control, CAPA and audit responses; support internal and external regulatory inspections.
• Liaise with IT, QA, laboratory management and vendors to ensure effective cross-functional collaboration.

Skills Required